Contact Lens Cleaning System With Monitor

ABSTRACT

The invention monitors the neutralization process involving hydrogen peroxide solution and a hydrogen peroxide neutralization catalyst and compares measured values with theoretical values. The system monitors the chemical reaction and notifies the user of the neutralization status. In an exemplary embodiment, the initial hydrogen peroxide solution concentration is neutralized with a palladium catalyst after a period of time. A microcontroller analyzes the measurements and displays the neutralization process results using colored LED lights and/or text or images on a LCD display. In one embodiment, an apparatus adapted for use with a cleaning solution used to clean a medical device may include a trigger, a processing device in communication with the trigger, and a display device. The processing device provides a trigger count and the display device communicates with the processing device and displays a message based on the count.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of and claims the benefit ofU.S. patent application Ser. No. 13/403,754 filed Feb. 23, 2102, whichclaims the benefit of U.S. Provisional Application Nos. 61/445,910,filed on Feb. 23, 2011 and 61/547,598, filed Oct. 14, 2011. Theforegoing applications are hereby incorporated by reference herein intheir entirety.

Incorporation by Reference

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

FIELD

The present invention relates generally to system for cleaning anddisinfecting contact lenses and method of use thereof. In variousrespects, the invention is directed to a system that monitors thecleaning solution neutralization process using a reaction sensor andcompares the measured values with theoretical values. The inventiondetermines if the process is proceeding properly or not, based on themeasurements obtained by the reaction sensor, and notifies the user ofthe status of the neutralization.

BACKGROUND

There are two main types of chemical disinfection systems for contactlenses, multipurpose and hydrogen peroxide-based systems. Hydrogenperoxide-based systems are often preferred, due to its rapid kill ofmicrobial contaminants, preservative-free packaging, low usersensitivity, and neutralization to natural by-products, such as waterand oxygen. The disadvantage of the hydrogen peroxide-based systems arethat they require memorization of what time the disinfection time wasstarted and figuring out when the neutralization process is complete.Also, if too much time has elapsed since the hydrogen peroxide solutionhas been neutralized, the sterile solution can eventually becomere-infected and foster microbial growth. One of the main reasons whyusers switch from hydrogen peroxide-based systems to multipurpose isbecause hydrogen peroxide-based systems require users to calculate whenthe ideal usage time is for each time that they disinfect their contactlenses, without knowledge of how effective the platinum catalyst isworking; that is, enough elapsed time has passed to ensure the peroxidehas been fully neutralized, to avoid chemical conjunctivitis andkeratitis, and short enough elapsed time to ensure microbes have notre-infected the sterile solution.

An example of a contact lens cleaning and sterilization system isdescribed in U.S. Pat. No. 4,687,997. This cleaning system requiresinsertion of the lenses into a disinfecting solution for a preset timeperiod followed by insertion into a neutralizing solution for a secondpreset time period. A first indicator shows a steady light while thedisinfectant is in the cleaning case and a second indicator when theneutralizing solution is in the case. The system distinguishes thedisinfecting solution from the neutralizing solution by measuring theelectrical conductivity of the solution within the cleaning case. Aftera predetermined amount of time, both lights flash to indicate the itemhas been disinfected and neutralized, respectively. This system does notmonitor the efficacy of cleaning, disinfecting or neutralization of thesolutions, however; the indicator lights flash to show completion of thedisinfecting and neutralization cycles solely in response to the passageof time.

Another example of a cleaning and sterilization system is described inU.S. Pat. No. 6,183,705. The system uses ultrasonic waves to cleancontact lenses, and heat to disinfect contact lens solution medium. Thesystem includes a housing, control circuit assembly, ultrasonicwaveguide, a heating rod with two electrodes and a graduated cleaningcup that is operated using the automatic control circuit. The controlcircuit includes a microprocessor for controlling the heating rod andthe ultrasonic waveguide. The microprocessor operates the ultrasoundtransducer for a preset time, then stops. After a rest time, themicroprocessor heats the cleaning solution to a preset temperature of90° C. as measured by a temperature sensor, then turns off the heatingrod, allowing the lenses to soak in the hot solution for another presettime. Once again, this system does not monitor the efficacy of thecleaning solution; the cleaning process always proceeds along the samepreset time intervals, and the indicator lights merely show which stagethe cleaning process is in.

SUMMARY OF THE DISCLOSURE

The present invention uses a hydrogen peroxide solution for cleaning anddisinfecting soft (hydrophilic) and rigid gas permeable contact lenses,and uses a platinum disk for peroxide neutralization. Neutralization isrequired to convert hydrogen peroxide to water and oxygen, so theresidual solution on the contact will not irritate the eye duringcontact lens insertion. The system monitors the cleaning solution withinthe device, and guides the user through the contact lens cleaningprocess with lights and/or textual directions.

The system may also monitor the internal and external temperatures andverify that the hydrogen peroxide solution is neutralizing properly. Themonitoring is done by verifying the exothermic peroxide-neutralizationprocess is occurring at an acceptable rate. Causes of poorneutralization can include old or expired peroxide solution, poorlystored cleaning solution, extreme solution temperatures, or the platinumdisc has decreased catalytic ability. The device can determine if theuser accidently used a bottle of saline solution, instead of a bottle ofhydrogen peroxide solution. If a bottle of saline solution is usedinstead of a bottle of hydrogen peroxide solution, the cleaning anddisinfection of the contact lenses will not occur increasing the risk ofinfection of the eye. Additionally, the device minimizes the desire torinse the contacts with saline solution after cleaning and prior toinsertion in to the eye; if hydrogen peroxide was mistakenly usedinstead of saline solution, chemical conjunctivitis or keratitis mayresult.

The present invention generally relates to an apparatus for cleaning anddisinfecting contact lenses. Provided herein are apparatus, systems andmethods for use with a cleaning solution used to clean a medical devicein which one or more messages are displayed to encourage compliance withthe normal medical device cleaning protocol.

The following embodiments, aspects and variations thereof are exemplaryand illustrative are not intended to be limiting in scope.

In one embodiment, a contact lens cleaning system includes a contactlens holder; a vial adapted to contain the contact lens holder and acleaning solution; a reaction sensor adapted to monitor a chemicalreaction rate of the cleaning solution; a processing device incommunication with the reaction sensor to receive a reaction signal fromthe reaction sensor; and a display in communication with the processingdevice, the processing device being adapted to operate the display toprovide cleaning efficacy information based on the reaction signal. Acatalyst element may be disposed within the vial and adapted to reactwith the cleaning solution. The reaction sensor may be a temperaturesensor. The temperature sensor may be disposed in a cap covering thevial or outside of the vial. The processing device may be adapted todetermine a temperature change rate from the reaction signal.

In an embodiment, the system may determine cleaning efficacy bycomparing the temperature change rate to a theoretical temperaturechange rate. The system may include an ambient temperature sensordisposed outside of the vial and may measure a temperature of airsurrounding the vial. The processing device may display cleaningefficacy information based on a temperature signal from the ambienttemperature sensor. The system may include a use counter communicatingwith the processing device. The processing device may displayinformation corresponding to the number of cleaning uses of the cleaningsystem.

The reaction sensor may be a pressure sensor. The system may include acaddy to support the vial. The display may be disposed within the caddy.The display may be disposed in a cap on the vial. The system may includea solution sensor disposed within the vial. The processing device maydetermine the presence of cleaning solution within the vial based on asignal from the solution sensor. The solution sensor may include anelectrode and/or a capacitive sensor.

In another embodiment, a method for cleaning a contact lens anddisplaying cleaning efficacy information includes receiving a contactlens into a contact lens holder, receiving cleaning solution into avial, wherein the vial containing the contact lens and contact lensholder, determining a chemical reaction rate of the cleaning solutionand cleaning efficacy information based on the chemical reaction rate,and displaying the cleaning efficacy information.

The vial may also contain a catalyst and the chemical reaction rate mayinclude a rate of chemical reaction between the cleaning solution andthe catalyst. The determining step may include monitoring temperature,monitoring temperature of the cleaning solution, monitoring temperatureexterior to the vial, calculating a temperature change rate, comparingthe temperature change rate to a theoretical temperature change rate,and/or monitoring temperature within the vial.

The method may include monitoring ambient temperature outside of thevial, such that the determining step includes determining the chemicalreaction rate from the temperature within the vial and the ambienttemperature. The method may include counting a number of contact lenscleaning uses and may display information related to the number ofcontact lens cleaning uses. The determining step may include monitoringpressure within the vial. The method may include determining whetherthere is cleaning solution in the vial prior to the step of determininga chemical reaction rate.

In another embodiment, the apparatus may include a cap assemblyconfigured to attach to a contact lens cup, a contact lens holderextending from the cap assembly into the cup, a solution sensor attachedto the cap assembly and configured to determine the presence of asolution within the cup, and a first temperature sensor attached to thecap assembly, a display and a microcontroller within the cap. Themicrocontroller may communicate with the solution sensor, the firsttemperature sensor and the display.

The solution sensor may be a pair of electrodes that measuresconductivity or a capacitive sensor. The apparatus may include acatalyst for neutralizing the solution and the solution may be hydrogenperoxide. The first temperature sensor may be a thermocouple or athermistor and may be positioned to measure a temperature of thesolution or of air surrounding the cup.

The apparatus may include a second temperature sensor. A secondtemperature sensor may be positioned to measure a temperature of airsurrounding the cup and may communicate with the microcontroller. Themicrocontroller may be adapted to receive conductivity data from theelectrodes, solution temperature data from the first temperature sensor,and air temperature data from the second temperature sensor. Themicrocontroller may output a signal based on the data.

The signal output by the microcontroller may drive an LED on the displayand may provide a text display on the display.

The text display may be provided through a liquid crystal display. Acapacitive touch sensor may be attached to the cap assembly. Theapparatus may include a battery for powering the microcontroller.

In another embodiment, a method for cleaning a contact lens anddisplaying a status of the cleaning process may include receiving acontact lens into a contact lens holder. A contact lens cleaningsolution may be received into a contact lens cup, and a determination ismade whether there is cleaning solution in the cup. If cleaning solutionis present in the cup, the method may include measuring the temperatureof the cleaning solution. The status of the cleaning may be determinedbased on the cleaning solution temperature. The status of the cleaningmay be displayed.

The temperature of air surrounding the cup may be measured. The statusof the cleaning may be determined based on the measured air temperatureand displayed on an LED display. The status may be displayed on amessage display. Determining the status of the cleaning may includemeasuring conductivity within the cup. Monitoring of the cleaningsolution may be initialized by a capacitive touch sensor.

In another embodiment, an apparatus for cleaning and disinfectingcontact lenses may include a cap assembly, a contact lens holder, acleaning solution, a catalyst, a first temperature sensor, a display,and a microcontroller. The cap assembly is configured to attach to acontact lens cup. The contact lens holder extends from the cap assemblyinto the cup. The cleaning solution is contained within the cup. Thecatalyst is contained within the cup and configured to neutralize thecleaning solution. The first temperature sensor is attached to the capassembly. The microcontroller is within the cap and communicates withthe first temperature sensor and the display.

In another embodiment, there is provided apparatus, systems and methodsfor use with a cleaning solution used to clean a medical device in whichone or more messages are displayed. The messages may inform the userabout the cleaning protocol or the condition of the cleaning system, andmay encourage compliance with proper cleaning protocols, includingmessages about when it is safe to use the medical device, when acleaning system should be replaced, and, in some cases, to consult ahealthcare professional.

Another embodiment provides for an apparatus which is adapted for usewith a cleaning solution used to clean a medical device, the apparatusincluding a trigger, a processing device in communication with thetrigger and which provides a count of the number of times the triggerhas been tripped, and a display device in communication with theprocessing device wherein the display device displays a message based onthe count. In certain embodiments, the medical device can be a contactlens. For example, the display device can display the message “Pleasereplace your case and solution” when a certain count has been reached,for example when the count is 180, which would be the count at sixmonths of daily use.

Another embodiment provides for an apparatus which is adapted for usewith a cleaning solution used to clean a medical device and may includea sensor that measures a property of the cleaning solution or a nearbyarea or the medical device; a processing device in communication withthe detector; a display device in communication with the processingdevice, wherein the display device displays a message based on theproperty of the cleaning solution or a nearby area or the medicaldevice. In certain embodiments, the cleaning solution comprises hydrogenperoxide. In certain embodiments, the medical device is a contact lens.In certain embodiments, the sensor is a temperature sensor, anelectronic sensor, a pressure sensor, a sound sensor, an optical sensor,or a gas sensor. In certain embodiments, the processing device comparesan input signal from the sensor to one or more preset values, andprovides one or more output signals depending on the comparison to thedisplay device. In certain embodiments, the display device is a light(e.g. an LED) or a liquid crystal display.

Another embodiment provides for an apparatus which is adapted for usewith a cleaning solution used to clean a medical device, comprising atemperature sensor that measures the temperature profile of the cleaningsolution or nearby area during the cleaning cycle; a processing devicein communication with the temperature sensor and storing in memory anacceptable temperature profile range; a timer; and a display device incommunication with the processing device, wherein different messages aredisplayed on the display device depending on whether the temperaturesensor measures a temperature profile that falls within or outside ofthe acceptable temperature profile range.

Another embodiment provides for an apparatus which is adapted for usewith a cleaning solution used to clean a medical device and whichprovides a message to a user, comprising a means for measuring aproperty of the cleaning solution or a nearby area or the medicaldevice; a processing means for (a) accepting an input signal; (b)providing a comparison of the input signal to one or more preset values;and (c) providing one or more output signals depending on thecomparison; and a means for displaying a message, wherein the message isbased on the output signal.

Another embodiment provides for a method of monitoring patientcompliance with a protocol for cleaning a medical device with a cleaningsolution, the method comprising obtaining data by measuring a propertyof the cleaning solution or a nearby area or the medical device, anddisplaying one or more messages according to the data. In someembodiments, the data may be provided to a medical professional.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIGS. 1A-1B illustrate an exemplary contact lens storage system.

FIGS. 2A-2B illustrate another exemplary contact lens storage system.

FIG. 3 illustrates an exemplary operational flowchart.

FIGS. 4A-4B illustrate another exemplary contact lens storage system.

FIG. 5 illustrates another exemplary operational flowchart.

FIGS. 6A-6B illustrate a top view and a side view, respectively, ofanother contact lens storage system.

FIG. 7 illustrates a side perspective view of a contact lens cleaningcase and monitor.

FIG. 8A illustrates a side view of the contact lens cap, lens basket,and platinum catalyst.

FIG. 8B illustrates a top perspective view of the contact lens capshowing the main internal components.

FIG. 8C illustrates another top perspective view of the contact lens capshowing an LED configuration.

FIG. 8D illustrates another top perspective view of the contact lens capshowing a LCD configuration.

FIG. 9 illustrates the rate of temperature increase of solution overtime.

FIG. 10 illustrates the rate of dependence on initial solutiontemperatures.

FIG. 11 illustrates the determination of equation of formula slope andy-intercept.

FIG. 12 illustrates the determination of rate in which air heats thesolution inside contact lens case.

FIG. 13 illustrates an example of thermistor RC time to temperatureconversion.

FIG. 14 illustrates a block diagram of a cleaning device for a medicaldevice.

FIG. 15 illustrates a block diagram of an exemplary temperature sensingcontact lens cleaning case.

FIGS. 16A-16B illustrates another exemplary operational flowchart.

FIG. 17 illustrates another exemplary contact lens storage system.

FIGS. 18A-18B illustrate a side view and top view, respectively, thecleaning case of FIG. 17.

DETAILED DESCRIPTION

The present invention relates to a system and method for monitoring theefficacy and status of a contact lens cleaning process, such as insystems using hydrogen peroxide and a neutralizing catalyst. One goal ofthe invention is to provide the user with an improved determination ofwhen the catalyst has reduced the peroxide concentration low enough toallow insertion of the contact lenses into the eye. The improveddetermination, which traditionally was done solely based on elapsed timeand uncorrected for solution temperature, may greatly reduce the risk ofchemical conjunctivitis cause by accidental peroxide burns of the eye.Accidental burns may be caused by incorrect usage of the hydrogenperoxide disinfection system, the use of expired peroxide solutions,poorly stored disinfection solution, extreme disinfection solutiontemperatures, rinsing contacts with hydrogen peroxide prior toinsertion, or the use of a platinum catalyst has decreased catalyticability.

Without knowledge of how effective the platinum catalyst is atneutralizing the cleaning solution, users may need to calculate when thesafe usage time is for each instance that they disinfect their contactlenses. That is, the user may need to determine when enough time haselapsed to ensure the peroxide has been fully neutralized, to avoidchemical conjunctivitis, and short enough elapsed time to ensuremicrobes have not re-infected the sterile solution. The presentinvention automatically does the calculations for the user, so the userdoes not have to; and the device evaluates the effectiveness of thechemical reaction that is taking place during the neutralization.

The system includes a cap assembly configured to attach to a contactlens cup or vial. Examples of cleaning cases that include a cap andcontact lens cup or vial are well known in the literature and mayinclude other features not shown herein. Examples of such cases can befound in U.S. Pat. Nos. 4,637,919, 4,750,610, 5,186,317, 5,366,078,5,558,846, 5,609,284, 5,609,837, and 6,148,992. Commercial examples ofsuch cases are found in or included as parts of the AOSEPT® DisposableCup & Disc (CIBA VISION®) and CLEAR CARE® (CIBA VISION®) systems.

A solution sensor may be attached to the cap assembly and configured todetermine the presence of a solution within the cup. In someembodiments, the system may include a reaction sensor. The reactionsensor may be adapted to monitor a chemical reaction rate of thecleaning solution. The reaction sensor may be implemented as atemperature sensor, an electric sensor, a pressure sensor, a soundsensor, an optical sensor, or a gas sensor. The system may include afirst temperature sensor attached to the cap assembly and a display. Afirst temperature sensor may be implemented as a first reaction sensorand may be configured to measure the temperature of the solution. Thesystem may further include a second reaction sensor in the form of asecond temperature sensor configured to measure the temperature of theair surrounding the cup. The cap assembly may include a microcontroller.The microcontroller may communicate with a reaction sensor, the solutiondetector, the capacitive touch sensor, the solution sensor, the firsttemperature sensor, a second temperature sensor, and/or the display, andsend an output signal based on the data.

In certain aspects, the apparatus, systems and methods described hereinmay have the following advantages. In certain aspects, they may providea convenient reminder to the user regarding whether cleaning isoccurring or progressing normally, when it is safe to use the medicaldevice, or when the medical device should be replaced. In embodimentswhere the apparatus, system or methods are used with a contact lenscleaner, they may improve user compliance with the procedures ofcleaning contact lenses as well as improve safety and cleanliness of thelenses. In certain aspects, using the apparatus, systems and methodsdescribed herein may increase the likelihood that lenses have beencleaned properly, may decrease the likelihood that contact lenses willbe re-infected after the cleaning procedure, or may decrease thelikelihood that lenses will irritate the eye after being cleaned. Forexample, for apparatus in which hydrogen peroxide-based cleaningsolutions are used, the apparatus described herein may indicate to theuser if the solution is potent (that is, if there is sufficient peroxidein the solution to clean the lens within the specified time), if thenormal cleaning cycle is complete and the lenses are safe to be placedin the eye, if the catalyst used to consume hydrogen peroxide isfunctioning properly or needs to be replaced, and other aspects of thecleaning protocol. In yet other aspects, apparatus described herein foruse with a contact lens cleaning system may display a signal or messagethat the user should consult his or her optician or eye-careprofessional. In certain aspects, using the contact lens storage systemsdescribed herein may increase patient or user compliance with the normallens cleaning protocol or other aspects of his or her eye care. Althoughsome of the aforementioned advantages pertain to contact lens cleaningsystems, these advantages may also pertain to corresponding apparatus,systems and methods adapted to be used to clean other medical devices,including dentures, endoscopes, catheters, ports, and so forth.

The term “caddy” refers to an apparatus adapted for use with a cleaningsolution used to clean a medical device. In certain embodiments, a caddymay be an apparatus into or onto which a separate cleaning case may beremovably placed. In other embodiments, a caddy may also be the cleaningcase, i.e. cleaning solution may be poured directly into parts of thecaddy.

The term “cleaning solution” refers to any liquid cleaning ordisinfecting solution used to clean medical devices such as contactlenses. Cleaning solutions may or may not include hydrogen peroxide orother peroxide compounds. Cleaning solutions may also include otheringredients. Examples of cleaning solutions which may be used inaccordance with the systems described herein include, withoutlimitation, AOSEPT® Disinfectant (CIBA VISION®) and CLEAR CARE® (CIBAVISION®).

The term “cleaning system” refers to a cleaning solution andaccompanying devices, such as a catalyst used to consume hydrogenperoxide in peroxide-based cleaning solutions.

The term “property” refers to a physical, chemical, electrical, optical,or other property, as well as a profile of that property over time.

Unless specifically noted otherwise herein, the definitions of the termsused are standard definitions used in the art of organic synthesis andpharmaceutical sciences. Exemplary embodiments, aspects and variationsare illustrated in the figures and drawings, and it is intended that theembodiments, aspects and variations, and the figures and drawingsdisclosed herein are to be considered illustrative and not limiting.

FIGS. 1A-B show caddy 150 and cleaning case 110. Referring to FIG. 1A,caddy 150 comprises caddy case 151, indicator 152, and display panel154. Caddy case 151 may be made out of an appropriate material, e.g. aplastic or similar type of material, which is well known in the art.Indicator 152 may be a light or an LED (light emitting diode), anddisplay panel may be an LCD (liquid crystal display) or a similardisplay panel capable of displaying text and/or graphical images eitherin color or black/white/grayscale. A display may be an indicator such asa light or an LED or a display panel such as an LCD. These componentsand structures are also well known in the art.

In some embodiments, caddy 150 may include a mechanism for providing anaudio indication of the solution status, temperature monitoring, andother information. For example, caddy case may include one or morespeakers and a controller or processor. The one or more speakers mayoutput audio from an acoustic signal provided by the controller orprocessor. The controller or processor may receive temperature or otherdata from one or more sensors. An audio message may be provided based onthe data provided by the sensors. For example, the caddy 150 may providean audio alert indicating the time remaining in the neutralizationprocess, the neutralization process is complete, the caddy isdisinfecting the contact lens, disinfection was successful orunsuccessful, the solution is not detected and other messages. Hence,the system of the present invention may provide audio alerts in place orin addition to visual or tactive alerts to communicate events orconditions related to contact lens, the solution, and other aspects ofthe present technology.

Referring to FIG. 1B, a separate and partially disassembled cleaningcase 110 is shown. Cleaning case 110 may comprise such elements as cap112, support beam 114, basket 116 and catalyst 118, and cylinder 120.Contact lenses, 117, are also shown. Examples of cleaning cases are wellknown in the literature and may include other features not shown herein,or modifications of the features shown herein. As shown, cleaning case110 may be fully assembled by reversibly affixing (e.g. by screwing,snapping, form-fitting, friction fitting, etc.) cap 112 onto cylinder120. The cylinder 120 of the embodiment illustrated in FIG. 1B includesthreads or screws 3 for affixing cap 112. The cylinder 120 of theembodiment illustrated in FIG. 1B includes threads or screws 3 foraffixing cap 112. Once fully assembled, the cleaning case may beremoveably placed in or on the caddy.

Referring to FIG. 2A, caddy 150 is shown in perspective side view, inwhich caddy case 151, indicator 152, and display panel 154 are alsoshown. FIG. 2B shows a cross-sectional view of caddy 150 and trigger160, which are electronically connected to processing device 170, whichis connected to and powered by power source 180. Processing device 170is also electronically connected to indicator 152 and display panel 154.Trigger 160 is positioned such that it is tripped under normal operationwhen cleaning case 110 is placed in or on caddy 150. Tripping thetrigger advances a counter within the processing device to provide acount. Processing device 170 may be a logic circuit, integrated circuitchip, or microprocessor, e.g. computing chip, or a plurality orcombination thereof. Similarly, a processor may take the form of a logiccircuit, integrated circuit chip, or microprocessor, e.g. a computerchip, or a plurality or combination thereof. Power source 180 may be abattery, e.g. a rechargeable battery or other type of battery typicallyused in small electronic devices. In some embodiments, the power sourcemay be a power source external to the caddy, e.g. a household 110 V orsimilar source. A small transformer, not shown, may also be needed.

Referring to FIG. 3, various aspects of operation of certain embodimentsof a caddy are shown. The process begins at step 301 after contactlenses and cleaning solution are placed in a cleaning case (e.g.cleaning case 110, FIG. 1A). At this time, the fully assembled cleaningcase should be placed into the base unit. A trigger (e.g. trigger 160,FIG. 2B) and the processing device to which it is connected (e.g.processing device 170, FIG. 2B) can be used to determine if the contactlens case has been placed into the base unit at step 302. If a cleaningcase has been placed therein, then a counter in the processing devicemay advance the count by one at step 304; if not, then the system may beplaced in “stand by” mode at step 303. If the count reaches a certainpreset indicator value at step 305, then the system can display amessage such as “Please replace case and solution” at step 307. Thepreset indicator or other values may be stored in a memory unit, whichmay be part of the processing device.

For example, if lens cleaning cases and solutions typically have auseful life of about six months, then the indicator value can be set at180 (assuming daily cleaning for six months). Other indicators valuescan be set, multiple indicators can be set for different messages, andthe indicator values can be changed. When the count reaches an indicatorvalue, the system can display an appropriate message to the user toencourage use of a new cleaning case and solution, thereby improvingcompliance with proper lens cleaning protocols. This procedure isrepresented by step 308. At this time, the systems can be reset, i.e.the counter can be reset to a zero value, for example by the userdepressing a button or switch on the base unit (not shown) or via anexternal computing device (also not shown). Referring back to step 305,if the indicator has not yet been reached, then the user can continuenormal operation of the cleaning system and may use it for a subsequentcleaning at step 306.

Messages may be in the form of a light, such as that from an LED orsimilar light, an audible signal such as a chime, bell, voice recording,etc., a tactile signal such as a Braille dot, or indicators displayingother signals. In one embodiment, when an indicator value in aprocessing device is reached, a red light is displayed. In anotherembodiment, a green light is displayed before the indicator value isreached, and when the indicator value is reached, the green light isturned off and a red light is on. Similarly, an audio signal such as abell, chime, or suitable voice recording can be triggered when theindicator value is reached.

Messages may also take the form of a text message or graphicaldepiction, which may be displayed on an LCD. One example of a textmessage is “Please replace your case and solution” which can bedisplayed when a counter reaches a certain preset value, indicating thatthe solution and/or catalysts may be nearing the end of its usefullifetime. One example of a graphical depiction is a graphicalrepresentation of a cleaning case or a bottle of cleaning solution. Moreexamples and details of messages are described below.

Additional examples of messages include the following: “Thank You forusing Clear Care Lens Solution;” “You can trust your eyes to AOSEPT®;”“Your contact lenses are being disinfected;” “It will take six hoursbefore your contact lens are ready for use;” “Your contact lenses areready for use;” “Please remove them only after you have washed yourhands with soap and water;” “Please discard your contact lens solutionas the solution is no longer active;” “It is now six months since yourcontact lens case was purchased. Please see your Optometrist.”

In various embodiments, a contact lens storage system can measure aproperty of (a) the cleaning solution, (b) the area near the cleaningsolution (also referred to as a nearby area) (e.g. the gaseous headspaceabove the cleaning solution) or (c) one or more of the medical devicesbeing cleaned. Examples of properties of the cleaning solution includetemperature, electrical conductivity, color, UV/V is absorbance, andprofiles thereof (e.g. temperature vs. time, etc.). Examples ofproperties of the nearby area include pressure, sound (e.g. soundgenerated by bursting bubbles at the solution/air interface),temperature, and profiles thereof Examples of properties of the medicaldevices include diffraction, dispersion or other property. Suchmeasurement can, via known calculations and/or comparisons in aprocessing device, be the basis of one or more messages relating towhether the cleaning solution is potent, working properly, needs to bereplaced, if the lenses are clean and ready to be removed for use, etc.

FIGS. 4A and 4B illustrate an embodiment of a contact lens storagesystem 400, showing cleaning case 110 removeably placed in base unit 450(also referred to as a caddy herein). Referring to FIG. 4A, in thisembodiment, base unit case 151 (also referred to as a caddy case herein)and display panel 154 are shown, as described above. Also in thisembodiment, there are two indicators 152A and 152B which may be, forexample, a red light and a green light, as described above. Depicted bydotted lines in this view are power source 180 (described above),temperature sensor 492, and circuit board 495.

FIG. 4B shows cleaning case 110 removeably placed in base unit 450 ofcontact lens storage system 400 in a view in which certain features arehidden from view and certain other features are described herein. Uponinsertion of cleaning case 110 into the base unit 450, trigger 460 maybe tripped and roller 461 may be deflected downward. Roller 461 may be aball, disc, or similar component. Trigger 460 may be, for example, amechanical switch (such as shown in FIG. 4B) or an optical switch suchas a combination of a LED IR emitter and photo detector (not shown).Temperature sensor 492 may be situated such that it can monitor thetemperature or temperature changes (i.e. temperature profile) of thecleaning solution during the cleaning cycle. Optional thermistor, 494,may be present in certain embodiments to measure the nearby temperature(e.g. the temperature external to the cleaning case). Trigger 460 andtemperature sensor 492 are connected to processing device 170 and allare powered by power source 180. In this embodiment, processing device170 is also connected to port 490. Port 490 may be, for example, a USBport to connect the system to a computer, smart-phone, or similardevice. A wireless connection (e.g. a BLUETOOTH®) may also be used.

Typically, when hydrogen peroxide is introduced to cleaning case 110containing catalyst 118, a chemical reaction occurs in which thecatalyst chemically reduces, and thereby consumes, the peroxide.Complete consumption of the peroxide is recommended before inserting alens into the eye, since ever trace amounts of peroxide can be verypainful to the eye. Heat is generated during this chemical reaction. Therate and degree of temperature increase during the reaction and decreaseafter the reaction can be measured and will be a function of the amountof peroxide in the solution and the amount of available catalyst sincecatalyst material, typically a metal such as platinum, is also oxidizedduring the reaction. Thus, in one embodiment, changes in the temperatureor temperature profile (i.e. the shape of a temperature vs. time curve)of the cleaning solution can be correlated to changes in the quality ofthe cleaning solution (e.g. amount of peroxide present) or the catalyst(how much catalyst is still available). A processing device can then beprogrammed to compare the temperature or temperature profile with apreset value. Thus, different messages can be displayed on the displaydevice depending on whether the temperature sensor measures atemperature profile that falls within or outside of the acceptabletemperature profile range.

Referring to FIG. 5, various aspects of operation of certain embodimentsof a contact lens storage system are shown. The process begins at step501 after contact lenses and cleaning solution are placed in a cleaningcase (e.g. cleaning case 110, FIG. 4B). At this time, the cleaning caseshould be inserted in the base unit. A trigger (e.g. trigger 460, FIG.4B) and the processing device to which it is connected can be used todetermine if the contact lens case has been placed into the base unit atstep 502. If a cleaning case has been placed therein, a message such as“Disinfecting” can be displayed on a display panel (e.g. display panel154, FIG. 4A) at step 503. If no cleaning case has been placed in thebase unit, the display panel can display a message such as “Standing By”at step 507 and the base unit can be said to be in “standby mode”. Afterthe trigger has been tripped, the temperature profile of the solution inthe cleaning case can be measured to determine if it falls within anacceptable temperature profile range at step 504. If “No” then a messagesuch as “Disinfection unsuccessful. Please replace case and solution.”can be displayed at step 505, after which the case can be removed atstep 506 and the “Standing By” message can be displayed at step 507. Ifthe temperature is found to be increasing within an acceptable range,then a timer can begin counting to a preset minimum disinfection time(“MDT”) time for normal disinfection of a pair of contact lenses at step508. At this time, a “Disinfection working properly” message can bedisplayed. This message can remain displayed as long as long as theelapsed time is not greater than the minimum disinfection time at step510. Once the elapsed time (“ET”) equals the minimum disinfection timeat step 510, a “Safe to Wear Lenses” or “Disinfection Complete” messagemay be displayed at step 511. For example, the minimum disinfection timecan be set at 6 hours. Other minimum disinfection times can be setaccording to such factors as how long it takes to measure thetemperature profile, the size and shape of the lens case and catalyst,and the recommended minimum time of disinfection specified by thecleaning system (e.g., CLEAR CARE®, etc.). If the case is then removedat step 512, the base unit is returned to standby mode. If the case isnot removed at step 512, then the timer continues to count. When theelapsed time measured by the timer reaches a preset upper limit of safestorage time (“SST”) at step 514, a message such as “Please restart thedisinfection process” can be displayed at step 515; if not, the “Safe toWear Lenses” message can remain displayed. For example, the upper limitof SST may be about 18 hours, about 24 hours, about 7 days, or anothertime depending on the cleaning system used. Since after this time therisk of re-infection may increase, it may be advisable to remove thelenses from the cleaning case before this time. As will be appreciatedby persons having ordinary skill in the art, the processing device,which can include one or more memory units, can store the values such asthe elapsed time, the safe storage time, etc. and can perform theabove-described comparisons and calculations.

Referring to FIGS. 6A-B, an embodiment where the caddy itself receivesthe cleaning solution (i.e. where there is no separate cleaning case) isshown. Referring to FIG. 6A, caddy 800 in side view is shown, includingcaddy case 851, made of plastic or some other suitable material,indicator 852, control buttons 853A and 853B, display 854, reservoirs820A and 820B, and caps 812A and 812B, which may be reversibly affixed(e.g. by screwing, snapping, form-fitting, friction fitting, etc.) tocaddy case 851. Certain of these components are shown in side view inFIG. 6B. This caddy may include features illustrated in the otherembodiments, and not explicitly shown here, such as a trigger, a timer,a processing device or a power source. The caddy shown in FIGS. 6A-B mayalso include a reaction sensor such as a temperature sensor, anelectronic sensor, a pressure sensor, a sound sensor, or a gas sensor.For example, caddy 800 may include a temperature sensor of the typeshown in FIG. 4B, or a pressure sensor (e.g. in caps 812A-B) of the typeshown in FIGS. 17-18. The caddy may also include buttons or tabs under aportion of where the caps are placed which are depressed when the capshave been reversibly affixed to the case. When depressed, a signal canthen be sent to the processing device to begin a timer or display amessage, similar to the trigger described above.

FIG. 7 illustrates a side perspective view of a contact lens cleaningcase and monitor according to one embodiment of the invention. Theembodiment of FIG. 7 has a contact lens cup 1 which is filled withbuffered hydrogen peroxide solution to the fill line 2.

FIG. 8A illustrates a side view of the contact lens cap, lens basket,and platinum catalyst. The contact lens cup 1 uses a screw 3 to secureit to the screw cap 4 of FIG. 8A. The solution temperature sensor 5monitors the temperature of the solution over time during the hydrogenneutralization process. In various embodiments, the solution temperaturesensor 5 may be a thermistor or a thermocouple. Using a solution sensor6, the microcontroller (not shown) senses that the contact lenses areimmersed into the solution and initiates the monitoring process. Thesolution sensor 6 may include two electrodes, one of which is shown onthe support beam of FIG. 8A. Solution sensor 6 may be located adjacentor near a top portion of lens basket 7 (not shown). The solution sensormay be a pair of conductivity electrodes. In various embodiments, whenthe presence of the solution is sensed using conductivity, themicrocontroller 11 may supply power to one electrode and measurescurrent at the other electrode. If current flows from one electrode tothe other, the microcontroller determines the cap is placed intosolution. The solution sensor may also be a capacitive sensor. Invarious embodiments, when the presence of the solution is sensed usingcapacitance sensors, the microcontroller may measure the capacitiveload. An example of simple way to measure capacitance is through the useof an RC circuit, where the charging or discharging time of theeffective capacitor is measured by the microcontroller; increasedcapacitance correlates with increased time. Examples of capacitivesolution sensors can be found in U.S. Pat. Nos. 2,409,073, 5,145,323,and 5,238,369.

A pair of contact lens baskets 7 holds the contacts in place during thecleaning process. A platinum catalyst 8 neutralizes the hydrogenperoxide solution, which is an exothermic process. The basket hinge 9allows the contact lens basket 7 to open, which allows the contacts tobe attached or removed.

FIG. 8B illustrates a top view of the contact lens cap showing the maininternal components. The main internal components of the contact lenscap may include a microcontroller 11, a reaction sensor such as anexternal temperature sensor 13, and a battery 12. The capacitive touchsensor 10 wakes the microcontroller 11 from low-power sleep mode. Thecapacitive touch sensor 10, commonly used in many hand-held devices suchas cell phone capacitive touch screens, may communicate with themicrocontroller 11 to identify hand touch. The microcontroller 11 maymeasure the capacitive load of the touch sensor 10. When a conductiveobject, such as a finger, gets in close proximity to a touch sensor, thecapacitive load changes. Examples of touch sensors can be found in U.S.Pat Nos. 4,186,392, 4,736,191, and 5,650,597. A battery 12 suppliespower to the device.

The external temperature sensor 13 measures the temperature of the airaround the cup 1 and corrects for external heating or cooling of thesolution. In various embodiments, the external temperature sensor 13 maybe a thermistor or a thermocouple. An example how the microcontroller 11may measure temperature through the use of a thermistor, is with the useof an RC circuit. The thermistor (for example a 33k NTC-type), which hasvariable resistance with respect to temperature, may be connected inparallel with a capacitor of known, fixed capacitance (for example 1000pF). The microcontroller initially charges the capacitor to a specifichigher voltage (for example, approximately 4.5V). When the initialvoltage is reached, the charging process is stopped, and time ismeasured for the thermistor to discharge the capacitor to a specificlower voltage (for example, approximately 1.4V). Since resistance of thethermistor is dependent on temperature, temperature can be easilycalculated by the microcontroller 11 by time measurements between thehigher and lower voltages. Measurement results from this example areillustrated in FIG. 13.

In one embodiment, the microcontroller 11 may measure temperaturethrough the use of a thermocouple by measuring the current generated bythe thermocouple, which is composed of two dissimilar thermoelectriccharacteristics. The current is converted to the digital signal, by ananalog-to-digital converter, for the microcontroller to process. Sincecurrent is dependent on temperature, the microcontroller 11 cancalculate the temperature based on this current. Examples of athermocouple can be found in U.S. Pat. Nos. 2,985,949 and 4,588,307.

FIG. 8C illustrates a top view of the contact lens cap showing a displayusing an LED configuration. The LED colored light or lights 14 of FIG.8C indicate(s) the status of the solution. FIG. 8D illustrates a topview of the contact lens cap showing a display using an LCDconfiguration. The optional LCD display 15 may supplement or replace theLED light or lights in communication of the status of the solution ordevice to the user. The status of the solution or device may includetext which reads “analyzing the solution's cleaning process”, “wait forsolution to complete cleaning process”, “safe to insert contacts intoeye”, “contacts unsafe to insert contacts into eye, redo cleaningprocess”, “cleaning process not functioning properly, replace solutionand/or case”, and “battery low”. The indications may be done by acolored LED light or lights such as for example red, yellow, orange,green, and short messages on the optional LCD display. The shortmessages may include “BATT”, “WAIT”, “OK”, “REDO”, “BAD”, “USE”, “SAFE”,“LOW”, “CLEANING”, “ANALYZE”, “REPLACE”. In some embodiments, anindication may be provided as an audio signal.

EXAMPLE 1

The exothermic reaction monitored by the reaction sensor of thisinvention can be illustrated by this example. The contact lens case wasa 20 mm diameter and a 2 mm thick plastic-walled reaction vessel such asthe one shown in FIG. 7. The contact lens case was thermally insulatedfrom the environment to negate external temperature influence. The casewas filled with 10 ml of disinfection solution (a solution of 3%hydrogen peroxide, 0.85% sodium chloride, phosphonic acid, and phosphatebuffer) at an initial temperature of 20.0° C. The contact lens capcontained a cogwheel-shaped, platinum catalyst disc (comparable to thecommon ˜10.4 cm²/1150 μg platinum catalyst currently commerciallyavailable and used in contact lens care). The thermal gradient wasrecorded over time with an imbedded thermocouple. For a 20° C. solution,the temperature initially increased at a rate of approximately 1.5° C.per minute. Since the solution's peroxide concentration decreases overtime, the rate of temperature change (exothermic reaction) begins toslow. One competing event is that exothermic reactions accelerate withan increase in temperature. The resulting reproducible temperatureprofile is illustrated in FIG. 9, which can be predicted with themathematical formula:

RATE (20° C.)=rate of temperature change without contribution fromexternal air temperature influence, when the solution in at 20° C.(Celsius/minute).

The formula may also be expressed as:

RATE (20° C.)=(0.00009×TIME³)−(0.0184×TIME)−(0.0248×TIME)+1.5611

where TIME is the reaction time (minutes).Although the curve appears to be polynomial, linear approximation canalso be used for simpler calculations:

RATE (20° C.)=(−0.124×TIME)+1.6725

The experiment described above was repeated at different initialsolution temperatures. FIG. 10 illustrates the reaction rate'sdependence on initial solution temperatures. As shown in FIG. 10, theexothermic reaction is dependent on the initial temperature of thesolution. A decrease in initial solution temperature has a decrease inrate of temperature change over time, while an increase in temperaturehas an accelerated rate of temperature change over time. FIG. 11illustrates the determination of equation of formula slope andy-intercept. As shown in FIG. 11, the slope and y-intercept of thesegraphs are fairly linear with respect to initial solution temperature.Thus, a simple mathematical calculation can be used to predict thetemperature rate of change at any time point for a given initialsolution temperature.

RATE (1)=rate of temperature change without contribution from externalair temperature influence (Celsius/minute).

The formula may also be expressed as:

RATE(1)=(((−0.008×IST)+0.037)×TIME)+((0.039×IST)+0.821)

Where IST is the initial solution temperature (Celsius) and TIME is thereaction time (minutes).

Since the mathematical calculation does not account for the external airtemperature warming the contact lens case, one can easily correct forthis. The experiment described above was performed at multiple ambientair temperatures. FIG. 12 illustrates the determination of the effect ofambient air temperatures on the heat of the solution inside contact lenscase during the exothermic disinfection process. The effect was found tobe linear with respect to the instantaneous temperature differencebetween the air temperature and solution temperature. The cooling effectalso fits this equation, where the air temperature was lower than thesolution temperature, although a negative value. Thus, the overall rateis:

RATE (2)=rate of change of solution temperature without contributionfrom the exothermic neutralization reaction (Celsius/minute) (rate thatair heats solution)

The formula may be expressed as:

RATE(2)=0.056×(CET−CST)

Where CST is the current solution temperature (Celsius) and CET is thecurrent external temperature (Celsius).

The THERORETICAL RATE may then be calculated as the overall rate ofchange of solution temperature. The theoretical rate may be expressedas:

THERORETICAL RATE=RATE(1)+RATE(2)

THERORETICALRATE=(−0.008×IST+0.037)×TIME+(0.039×IST+0.821)+0.056×(CET−CST)

This equation only fits a specific contact case design, solutionformulation, peroxide concentration, and catalyst design and quality.This is advantageous, since an abnormally high or low peroxideconcentration and/or a reduction in quality of the platinum catalyst canbe easily identified by a comparison of theoretical and actualtemperature measurements.

A method for using the device may begin when a user places contactlenses into the contact lens baskets 7 of the contact lens cap 4, andcloses the baskets 7. The contact lens case cup (reaction vessel) 1 isfilled with hydrogen peroxide disinfection/cleaning solution up to thefill line 2. The contact lens cap 4 is grasped by the user's hand. Theuser's hand is sensed by the capacitive touch sensor 10, which wakes themicrocontroller 11 from low-power mode. The microcontroller 11 thenmonitors the solution sensor 6 to sense when the contacts lenses areimmersed in to the solution. For purposes of discussion, conductivityelectrodes are used as an example of the solution sensor. The exemplarysolution sensor is not intended to be limiting. The microcontroller 11may sense when the contact lenses are immersed because the solutioncontains ions which allow electricity to flow from one electrode to theother. Since the conductivity electrodes 6 are located near or above thesolution temperature sensor 5, contact lenses, and fill line 2, there isconfirmation that there is sufficient solution added to the contact lenscase cup (reaction vessel) 1. The conductivity electrodes 6 signal themicrocontroller 11 to initiate the monitoring of the contact lenssolution and to start the reaction timer. For example, themicrocontroller 11 may cause a yellow LED light 14 to blink rapidly or adisplay to provide the message “ANALYZE” on the LCD display 15. Themicrocontroller 11 would then take an initial solution temperaturemeasurement (IST). In various embodiments, the microcontroller 11 maytake a solution temperature measurement with a solution thermistor orthermocouple 5 at 1.5 minutes and 0.5 minutes and take the difference ofthese two numbers (ACTUAL RATE); the microcontroller 11 will also take ameasurements at 1.0 minute (TIME=1.0) with solution thermistor orthermocouple 5 (CST), and a measurement with external temperature sensor13 (CET). The values may be used in the following example equation:

THEORETICALRATE=(−0.008×IST+0.037)×TIME+(0.039×IST+0.821)+0.056×(CET−CST)

For example, if the ACTUAL RATE is within +/−20% of the THEORETICALRATE, the device identifies that the solution and platinum catalyst areperforming as expected; the device may then slowly blink a yellow LEDlight 14 or display “CLEANING” on the LCD display 15. For example, ifthe ACTUAL RATE is not within +/−20% of the THEORETICAL RATE, the deviceidentifies that the solution and platinum catalyst are not performing asexpected; the device may blink a red LED light 14 or display “REDO” or“BAD” on the LCD display 15.

If the device identified that the solution and platinum catalyst areperforming as expected, a specific time will be allowed to elapse whichis appropriate for the complete neutralization of the hydrogen peroxideat the given solution temperature (approximately 6 hours at 20° C.). Atthis point, the contacts are considered ready to wear, and the devicemay then slowly blink a green LED light 14 or display “USE” or “SAFE” or“WEAR” on the LCD display 15. If the conductivity electrodes 6 andcapacitive touch sensor 10 do not sense that the screw cap 4 was removedfrom the contact lens cup 1 which contains the neutralized solution, thedevice may then slowly blink a green LED light 14 up to the point wherethe contact lens are not longer safe to place into the eye at the givensolution temperature (approximately 7 days at 20° C.). At this point,the device may then slowly blink a red LED light 14 or display “REDO” onthe LCD display 15.

The device may also count the number of times the cleaning process waspreformed, and blink a red LED light 14 or display “BAD” or “REPLACE” onthe LCD display 15 after the maximum number of uses was exceeded. Anaudio indication may also be provided to indicate the maximum number ofuses was exceeded. The device may also count the number of days thathave elapsed after the initial use, and blink a red LED light 14 ordisplay “BAD” or “REPLACE” on the LCD display 15 after the maximumnumber of days was exceeded.

FIG. 14 illustrates a block diagram of a cleaning device 700 for amedical device. Cleaning device 700 has a microcontroller 704 that ispowered by the power supply 702. The microcontroller 704 controls andcommunicates with the display/user interface 701, reaction sensor 703,and memory 705. The device's operation program and user data is storedon the memory 705, and the information is accessed on demand by themicrocontroller 704. The microcontroller's program may be initiated by asignal from the reaction sensor 703 or from a signal from the user, viathe display/user interface 701, such as a display touch screen. Themicrocontroller 704 takes readings from the sensor over time, makescalculations with the measurements and the data stored in the memory,and displays a result on the display/user interface 701.

FIG. 15 illustrates a block diagram of an exemplary temperature sensingcontact lens cleaning case 706. The cleaning case 706 has amicrocontroller 708 that is powered by the power supply 713. Themicrocontroller 708 monitors the solution sensor 711 to sense whensolution is present. When the microcontroller 708 determines thatsolution is present, readings from air temperature sensor 709 andsolution temperature sensor 710 are obtained. These readings, combinedwith calibration data stored in the memory 712, are converted totemperature measurements by the microcontroller 708. The microcontroller708 then stores these historical temperature measurements in the memory712 for later retrieval. After a specific duration, the temperaturemeasurements are recalled from the memory 712 by the microcontroller708. The microcontroller 708 determines what signals should be sent todisplay 707.

FIGS. 16A-B illustrate an example of an operational flow chart for usinga three light LED display configuration. The flow of operation describedherein is for illustrative purposes and is not intended to be limiting.In various embodiments, the process begins at step 720 when the cleaningcase (e.g. cleaning vial FIG. 7 and cap FIG. 8A) is powered on. In someembodiments, the device is normally in low-power sleep mode at step 721to preserve limited battery life. The device may wake up from low-powersleep mode every 1 to 3 seconds for a period of a few microseconds tosense if cleaning solution has been added to the device at step 722. Ifno solution is detected, the device goes back into sleep mode. Ifsolution is detected, the device blinks the yellow LED quickly at step723. For example, the device LED may blink twice per second. Quickblinking may indicate the device is determining if the cleaning solutionand system are functioning properly. The device delays 5 to 15 secondsbefore taking a baseline temperature measurement at step 724, to allowfor temperature equilibration of the cleaning solution, vial, and cap.After equilibration, initial solution and atmospheric temperaturemeasurements are taken at step 725. The solution temperature is used asa reference point, in which future solution temperature rates can bedetermined. Since the cleaning solution can either be heated by theexothermic chemical reaction or the heat from the environment, it isuseful to take atmospheric temperature measurements. Once the airtemperature is known, atmospheric heating of the solution can befactored out, thereby giving a more accurate measurement of chemicalheating. The device routinely detects if the cap is continuouslyimmersed in solution at step 726.

If no solution is detected at step 726, the LED will blink red at step730, indicating that the cleaning process has been interrupted and thatit is unsafe to place the contact lenses into the eye. The red blinkingLED continues to blink for 30 seconds, followed by return to low-powersleep mode at the start of the sequence. If solution is detected, themicrocontroller delays for 30 seconds at step 727. Solution andatmospheric temperature measurements are re-sampled or taken at step728. The device routinely detects if the cap is continuously immersed insolution at step 729, and the process proceeds if solution is detected.Theoretical temperature rate is calculated at step 732 from the solutiontemperature measurements and corrected by the atmospheric temperaturemeasurements. If the actual temperature rate is not within 20% of thecalculated theoretical temperature rate at step 733, then the LED blinksred to indicate that the lenses are not safe to insert into the eye atstep 741. After 30 seconds, the device may continue to wait until nosolution is detected at step 742, and then the process returns to startat step 743.

If the actual temperature rate is within 20% of the calculatedtheoretical temperature rate at step 733, then the device blinks theyellow LED slowly at step 734, for example once per 2 to 3 seconds. Thepurpose of the slowly blinking is to indicate that the device hasdetermined that the cleaning solution and system are functioningproperly, and the device is cleaning the contact lenses. The devicedetects if the cap is continuously immersed in solution at step 735. Ifsolution is detected, the device proceeds to allow 6 hours for thecleaning solution to complete the cleaning/neutralization cycle at step736. If 6 hours has elapsed, the device blinks the green LED slowly atstep 737, which indicates to the user that the device has finished thecleaning/neutralization cycle, and the contact lenses are safe to insertinto the eye. The device continues to blink the green LED until nosolution is detected at step 738, where it returns to the start at step743. If solution is continued to be detected at step 738, and 7 days haselapsed at step 739, then the LED blinks red at step 740 to indicatethat it is no longer safe to insert the contact lenses into the eye.This is due to a possibility that microbes may have re-infected thesterile solution. The red LED will continue to blink until no solutionis detected at step 744.

FIG. 17 illustrates an embodiment of a system 600 comprising a cleaningcase 610 and a caddy 680, in which pressure in the headspace above thecleaning solution is measured within the cleaning case, and messagesbased on the pressure profile are displayed on the caddy. Cleaning case610 includes cap 630 and may also include aforementioned components, notshown here, such as a basket for holding contact lenses, a catalyst, andothers. In this embodiment, cap 630 includes case contacts 650A and650B. Also shown is caddy 680, which includes features described abovesuch as caddy case 151, indicators 152A and 152B, and display panel 154.Also shown are caddy contacts 670A and 670B.

Still referring to FIG. 17, case contacts 650A and 650B make electricalcontact with caddy contacts 670A and 670B when the case is placed incaddy 680. In this way there is an electrical communication between thecase and the caddy to enable other features of this system. Cleaningcase 610 also includes cylinder 620, which may have an orientingcomponent for rotationally positioning the cleaning case once it isplaced in the caddy such that case contacts 650A and 650B make propercontact to caddy contacts 670A and 670B. Such orienting component may bea fin, such as fin 621 shown, or may be a groove, bump, dimple, orsimilar structure. In such case, the caddy will also include acorresponding receiver, not shown, which can receive or mate with thestructure on the cylinder. Such receiver can be a groove, fin, dimple ornotch, and is not shown in the figure. For example, caddy 680 caninclude a groove to receive fin 621 when case 610 is placed in thecaddy. Other mechanisms for properly orienting the case in the caddy maybe easily envisaged.

Referring to FIG. 18A, certain components and additional features of theembodiment of the cleaning case illustrated in FIG. 17 are shown. FIG.18A shows a side view of cap 630 of the cleaning case shown in FIG. 17.

As explained above, when a peroxide-based cleaning solution and catalystare used, an oxidation-reduction reaction occurs. During this reaction,oxygen bubbles are generated at the catalyst. These bubbles float to thesurface of the solution, whereupon oxygen gas is released. If the capmakes a reasonably gas-tight seal onto the cylinder, pressure in theheadspace above the solution will increase as gas is released. Freshsolutions and catalysts will generate more gas than old ones. Messagesinforming a user about the quality and useful life of the cleaningsolution and catalyst can be generated using these concepts.

Still referring to FIG. 18A, cap 630 includes several components whichcan measure the pressure of gas generated by the reaction of a peroxidewith a catalyst, i.e. a reaction sensor in the form of a pressuresensor. Internal port 632 allows gas from headspace 631 to enter bladder633 where it pushes against diaphragm 634. As the pressure builds,diaphragm 634 pushes against shorting bar 636, which is disposed againstspring 638 towards cap top 643 until it contacts pins 646A and 646B.Pins 646A and 646B are connected to wires 640A and 640B, respectively,which are connected to case contacts 650A and 650B, respectively.

After a cleaning cycle is initiated and case 610 is placed in caddy 680(FIG. 17), gas is generated by the chemical reaction. When shorting bar636, which is electrically conductive, contacts pins 646A-B, anelectrical connection is made between the two pins and a connecting to alogic chip is completed. Thus, a signal can be sent to a processingdevice so that a message can be displayed and/or a timer can also bestarted to display messages at a later time. For example, upon shortingbar 636 making a connection to pins 646A and 646B, a message such as“Your Contact Lenses are Being Cleaned” can be displayed, e.g. indisplay 154 (FIG. 17). At this time a timer can count to a specifiedtime, e.g. 6 hours, at which time a message such as “Your Contact Lensesare Clean and Ready for Use” can be displayed. Alternatives can beeasily envisaged.

Referring again to FIG. 18A, external port 642 allows air to escape asdiaphragm 634 and shorting bar 636 are disposed towards cap top 643. Cap630 may also include an overflow port 644 opened by overflow valve 648.In some cases when the pressure in the headspace exceeds a certainamount, such a system can allow excess gas to escape from the headspace.

FIG. 18B shows a top-down view of the cap shown in FIG. 18A. This viewshows shorting bar 636, spring 638, external port 642, overflow port644, pins 646A-B, and case contacts 650A-B. In the embodiment shown inFIGS. 18A-B, the shorting bar 636 is shown as a disc, however it maytake any other appropriate shapes, such as that of a pin or rod, anoval, etc.

The examples above describe in detail embodiments in which thetemperature of the solution is measured with a temperature sensor, andanother embodiment in which pressure of gas generated by a reaction ofperoxide with a catalyst is measured by a pressure sensor. However, thisdisclosure encompasses additional embodiments wherein other ways ofmeasuring or sensing a property using a sensor may be used. Such sensorsmay be, for example and without limitation, an electronic sensor (whichincludes a sensor of conductivity, voltage, or other electronicproperties, e.g. between two electrodes), a sound sensor, an opticalsensor, or a gas sensor. For example, in one embodiment, a caddy mayinclude two electrodes (the catalyst can be one electrode) which contactthe cleaning solution. Differences in the conductivity or voltage overtime as the reaction of peroxide with the catalyst progresses can bemeasured using a reaction sensor and used to initiate a timer or displayone or more messages, as described above. In other embodiments, othertypes of sensors may be used to drive similar processes.

Also provided are methods of monitoring patient compliance with aprotocol for cleaning a medical device with a cleaning solution, themethods comprising obtaining data by measuring a property of thecleaning solution or a nearby area or the medical device, and displayingone or more messages according to the data. The data obtained from themeasurements (“measurement data”) may be compared to preset data storedin memory, and the one or more message may be based on a comparisonbetween the measurement data and the preset data. In some embodiments,the data may be provided to a medical professional. For example, in onemethod, data from measuring the temperature or temperature profile of acleaning case may be obtained and compared to preset data, e.g. anacceptable temperature profile range (see discussion of FIG. 5, above).If the measurement data is within the acceptable range, a message suchas “Disinfection working properly” can be displayed; if not, then amessage such as “Disinfection unsuccessful” can be displayed. Data for aseries of cleaning events can be stored over time. This data can beprovided to or accessed by the user or a healthcare professional suchas, in embodiments where the medical device is a contact lens, anoptician. For example, the user or medical professional can access thedata with a computer, smartphone, or similar computing device. The datamay provide a history of the user's cleaning regimens over a certaintime, e.g. six months or a year. With this method, the user and opticiancan monitor and improve compliance with the cleaning protocol.

Any of the apparatus or systems (e.g. caddies) or methods describedherein may have the following additional features or components. Theymay include a first sensor and a second sensor, wherein the first andsecond sensors are each one of the sensors described above (thermal,optical, etc.) and wherein the first sensor measures a property relatingto the oxidation/reduction reaction of the peroxide and catalyst (e.g.temperature changes, conductivity or voltage changes between electrodes,pressure, sound, etc.) and the second sensor measures a certain“signature” of the solution. The signature may be, for example, a uniqueoptical absorptivity of one supplier's cleaning solution absent in othercleaning solutions. The caddy can be programmed to operate only whenthis “signature” is detected. Thus, a caddy can be made to operate onlywhen a particular supplier's cleaning solution is used. In someembodiments, the apparatus or system can include a selector switch orsimilar input device in which the user selects the frequency at whichthey replace their contact lenses. For example, a selector switch caninclude options for daily, weekly, bi-weekly, or monthly replacement.Such a selection, which can also be made with a computer or similardevice, can send a signal to the processing device so that a message canbe displayed suggesting the user replace his or her contact lenses.

While a number of exemplary embodiments, aspects and variations havebeen provided herein, those of skill in the art will recognize certainmodifications, permutations, additions and combinations and certainsub-combinations of the embodiments, aspects and variations. It isintended that the following claims are interpreted to include all suchmodifications, permutations, additions and combinations and certainsub-combinations of the embodiments, aspects and variations are withintheir scope. This, in the context of this disclosure, although atemperature sensor and a pressure sensor may not be structuralequivalents, in that a temperature sensor may measure temperature usingan infrared detector and a pressure sensor may measure pressure of agas, in the context of measuring a property of a cleaning solution, thearea near a cleaning or one or more of the medical devices beingcleaned, a temperature sensor and a pressure sensor may be equivalentstructures.

What is claimed is:
 1. A contact lens cleaning system comprising: acontact lens holder; a vial adapted to contain the contact lens holderand a cleaning solution, wherein a catalyst is capable of neutralizingthe cleaning solution; a sensor capable of providing data on a rate ofneutralization of the cleaning solution; a processing device incommunication with the sensor to receive the rate of neutralization datafrom the sensor; and a display in communication with the processingdevice, the processing device being adapted to operate the display toprovide cleaning efficacy information based on the rate ofneutralization data.
 2. The system of claim 1 wherein the sensor is atemperature sensor.
 3. The system of claim 2 wherein the processingdevice is adapted to determine a temperature change rate from the rateof neutralization data.
 4. The system of claim 3 wherein the processingdevice is further adapted to determine cleaning efficacy by comparingthe temperature change rate to a theoretical temperature change rate. 5.The system of claim 4 further comprising an ambient temperature sensordisposed outside of the vial and adapted to measure a temperature of airsurrounding the vial, the processing device being further adapted todetermine cleaning efficacy using a temperature signal from the ambienttemperature sensor to correct for ambient temperature affect to theapproximate rate of temperature change as compared to the theoreticaltemperature change rate.
 6. The system of claim 1 further comprising ause counter communicating with the processing device, the processingdevice being further adapted to display information corresponding to thenumber of cleaning uses of the cleaning system.
 7. The system of claim 1wherein the sensor is a pressure sensor.
 8. The system of claim 1further comprising a solution sensor disposed within the vial, theprocessing device being further adapted to determine the presence ofcleaning solution within the vial based on a signal from the solutionsensor.
 9. The system of claim 1 wherein the catalyst comprisesplatinum.
 10. The system of claim 1 wherein the cleaning solutioncomprises hydrogen peroxide.
 11. The system of claim 1 wherein thesensor is a conductivity sensor.
 12. The system of claim 11 wherein theprocessing device is adapted to determine a conductivity change ratefrom the rate of neutralization data.
 13. The system of claim 12 whereinthe processing device is further adapted to determine cleaning efficacyby comparing the conductivity change rate to a theoretical conductivitychange rate.
 14. A contact lens cleaning system comprising: a contactlens holder; a vial adapted to contain the contact lens holder and acleaning solution, wherein a catalyst is capable of neutralizing thecleaning solution; a sensor capable of providing data on acharacteristic of the neutralization of the cleaning solution; aprocessing device in communication with the sensor to receive the datafrom the reaction sensor and determine an approximate rate ofneutralization using the data; and a display in communication with theprocessing device, the processing device being adapted to operate thedisplay to provide cleaning efficacy information based on theapproximate rate of neutralization.
 15. The system according to claim14, wherein the characteristic of the chemical reaction is temperatureresulting from heat produced by the neutralization of the cleaningsolution, and wherein the sensor is a temperature sensor.
 16. The systemaccording to claim 15, wherein the processing device is further adaptedto determine cleaning efficacy by comparing the approximate rate oftemperature change to a theoretically determined rate of temperaturechange for the neutralization of the cleaning solution.
 17. The systemaccording to claim 16 further comprising an ambient temperature sensordisposed outside of the vial and adapted to measure a temperature of airsurrounding the vial, the processing device being further adapted todetermine cleaning efficacy using a temperature signal from the ambienttemperature sensor to correct for ambient temperature affect to theapproximate rate of temperature change as compared to the theoreticallydetermined rate of temperature change.
 18. The system according to claim14, wherein the characteristic of the neutralization of the cleaningsolution is pressure resulting from a gas product from theneutralization, and wherein the sensor is a pressure sensor.
 19. Thesystem according to claim 18, wherein the processing device is furtheradapted to determine cleaning efficacy by comparing the approximate rateof pressure change to a theoretically determined rate of pressure changefor the neutralization.
 20. The system according to claim 14 wherein thecatalyst comprises platinum.
 21. The system according to claim 14wherein the cleaning solution comprises hydrogen peroxide.
 22. Thesystem according to claim 14, wherein the characteristic of theneutralization of the cleaning solution is conductivity resulting fromthe neutralization of the cleaning solution, and wherein the sensor is aconductivity sensor.
 23. The system according to claim 22, wherein theprocessing device is further adapted to determine cleaning efficacy bycomparing the approximate rate of conductivity change to a theoreticallydetermined rate of conductivity change for the neutralization of thecleaning solution.
 24. A contact lens cleaning system comprising: acontact lens holder; a vial adapted to contain the contact lens holderand a cleaning solution; a sensor capable of generating data related toa rate of neutralization of the cleaning solution; a processing devicein communication with the sensor to obtain the data and determine anapproximate rate of neutralization of the cleaning solution using thedata; and a display in communication with the processing device, theprocessing device being adapted to operate the display to providecleaning efficacy information based on the approximate rate ofneutralization.
 25. The contact lens cleaning system according to claim24, wherein neutralization of the cleaning solution is catalyzed by acatalyst.